2. Urology Department, South Egypt Cancer Institute, Assiut University, Egypt.
Background: BCG is the standard treatment for non-muscle invasive bladder cancer (NMIBC). However, the high recurrence rates and the significant local and systemic toxicity have led to increased interest in alternative intravesical therapies. Docetaxel has been shown to be a safe and effective intravesical therapy with no systemic absorption and minimal toxicity.
Objectives: To compare the efficacy and safety of intravesical BCG and docetaxel for intermediate and high-risk NMIBC.
Patients and methods: 82 patients with NMIBC were randomized into 2 groups; and treated with six weekly intravesical BCG (group I, 40 patients) and docetaxel (group II, 42 patients). Outcome measures were overall recurrence rate, progression rate, 1-year recurrence free and progression free survival. Treatment related toxicities were also evaluated.
Results: No difference between the 2 groups in recurrence rate (32.5% vs. 42.9%), progression rate (20% vs. 28.6%), 1-year recurrence free survival (72.5% vs. 61.9%), 1-year progression free survival (80% vs.71.4%). No difference for intermediate and high risk patients in BCG group and their counterparts of docetaxel group in recurrence rate (16.7% vs. 42.9%) and (39.3% vs. 42.9%), progression rate (16.7% vs. 14.3%) and (21.4% vs. 35.7%), 1-year recurrence free survival (83.3% vs. 76.9%) and (67.9% vs. 53.6%), 1-year progression free survival (83.3% vs. 84.6%) and (78.6% vs. 65.5). Age, grade and multiplicity were independent predictive factors for recurrence while grade was the independent factor for progression. The adverse events of BCG group were more marked.
Conclusions: Intravesical docetaxel demonstrate significant efficacy and minimal toxicity for the management of NMIBC. In comparison to BCG, there was no significant difference in terms of disease recurrence, progression or survival, and the decision to use either agent may be based on adverse events and cost. The results of this study support the role of intravesical docetaxel for intermediate risk patients and it can be of major concern for high risk patients, however, randomized multiinstitutional trials should be considered.
Keywords: Bacillus Calmette-Guérin, docetaxel, intravesical therapy, NMIBC